MAUDE Adverse Event Report: MEDTRONIC; MEDTRONIC YANKAUER IN MAJOR JOINT PACK-LF

Catalog Number DYNJ0516998I

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that during a left total shoulder procedure, the yankauer tip broke off and fell into the surgical site.This incident reportedly occurred during "regular use" of the device.The or staff was required to search the surgical site and visually retrieve the broken yankauer tip pieces.No information was provided to the manufacturer as to what instruments were used during the retrieval process or how many yankauer tip pieces were retrieved from the surgical site.The patient was under general anesthesia at the time of this incident.Reportedly, the procedure lasted longer than expected but the patient did not require additional anesthesia.No impact to patient stability reported.No serious injury, additional medical intervention, or follow-up care reported.No sample was returned to the manufacturer for evaluation.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that during a left total shoulder procedure, the yankauer tip broke off and fell into the surgical site.

• Type of Device: MEDTRONIC YANKAUER IN MAJOR JOINT PACK-LF
• Manufacturer (Section D): MEDTRONIC; 710 medtronic parkway; minneapolis MN 55432 5604
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 7507107
• MDR Text Key: 108028818
• Report Number: 1423395-2018-00026
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10889942072262
• UDI-Public: 10889942072262
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: DYNJ0516998I
• Device Lot Number: 17LK2807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR